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6-Hour Virtual Seminar on Qualification (IQ, OQ, PQ) and Validation of Laboratory Equipment and Systems for Regulated Industries (Pharma, Biotech, Devices) - Webinar

  • ID: 4833644
  • Webinar
  • July 2021
  • Region: Global
  • 360 Minutes
  • NetZealous LLC
UP TO OFF
until Nov 30th 2021
This webinar will aim at understanding and scoping out various phases of Qualification activities that will be integrated with the perspectives of Instrument Control, System Suitability Test (SST), Analytical Methods Validation and ensuring Data Integrity for Regulatory Compliance.

Why you should Attend: This is an area of growing concern, sometimes ridden with uncertainty as to what needs to be done at each of stages of the Product Lifecycle.

In modern Pharmaceutical and Biotech laboratories, a composite array of various gadgets, devices, analytical instruments and computerized systems are used daily.

Agenda:

Session 1
  • Introduction
  • Quality Systems, Paradigm Shift, Global Perspectives
  • QA/QC Validation
  • Risk Assessment
Session 2
  • Measurement, Resolution, Errors, and Uncertainty
  • Regulatory and QS Requirements
  • The Product Life Cycle Concept
  • USP chapter 1058
  • Examples of Various Systems
Session 3
  • Strategies for Validation
  • Documentation /Master Validation Plan
Session 4
  • Training Requirements
  • Examples of Various Systems
Note: Product cover images may vary from those shown
Session 1
  • Introduction
  • Quality Systems, Paradigm Shift, Global Perspectives
  • QA/QC Validation
  • Risk Assessment
Session 2
  • Measurement, Resolution, Errors, and Uncertainty
  • Regulatory and QS Requirements
  • The Product Life Cycle Concept
  • USP chapter 1058
  • Examples of Various Systems
Session 3
  • Strategies for Validation
  • Documentation /Master Validation Plan
Session 4
  • Training Requirements
  • Examples of Various Systems
Note: Product cover images may vary from those shown
Joy McElroy Upon earning a degree in Zoology at North Carolina State University, Joy began working in the pharmaceutical and biotech industries in 1992 at Pharmacia & UpJohn performing Environmental Monitoring and Sterility Testing. Her work allowed her to move into a supervisory role at Abbott Laboratories where she oversaw the Quality Control Lab.

In 1998 Joy moved to Wyeth Lederle and worked in Quality Assurance, performing GMP Compliance audits, batch record reviews, and holding annual GMP training for new employees. After working in Quality Assurance for a few years, Joy moved into Equipment Qualification and Cleaning Validation at Mallinckrodt.

With 19 years of experience as a consultant, and over 25 years total experience in the pharmaceutical and biotech industries, Joy has gained extensive knowledge of Quality Assurance, Technical Writing, Process and Cleaning Validation, and Equipment Qualification and Computer System Validation and Part 11 Compliance. She has written and executed Equipment Qualifications and Validation Protocols for numerous Companies such as Mallinckrodt, Wyeth Lederle, Merck, BioMerieux, Catalent, and Biotest, Novartis, Imprimis, Cody Laboratories, and Xceilence.
Note: Product cover images may vary from those shown
  • Scientists
  • Managers
  • R&D Personnel
  • Quality Assurance/Quality Control Staff
  • Validation Managers
  • Validation Coordinators
  • Production and Process Development Personnel
  • Regulatory/Compliance Managers
  • Chemists
  • Technicians Study Directors(GLP)
  • Qualified Persons (EMEA)
  • Pharmaceutical Development
  • CRO Staff
  • CRO Managers, Accredited Laboratories in general
  • Any one engaged with Test Methods
Note: Product cover images may vary from those shown
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